Posted 13 January 2014
By Alexander Gaffney, RAC
It may not be the social media guidance members of the pharmaceutical industry have be clamoring for, but the US Food and Drug Administration (FDA) today released a draft guidance document that offers some insight into how the agency thinks companies should use-and not use-social media channels.
The pharmaceutical industry's advertising and promotional materials are tightly regulated by FDA and the Federal Trade Commission (FTC), the latter of which has vested its advertising review authority with FDA.
Each advertisement must contain a variety of elements, including facts backed up by substantial and cited evidence, a full accounting of risks, a "fair balance" of benefits and risks of the drug, the generic name of the drug, any serious warnings such as Black Box warnings and more.
The amount of information required, in other words, is extensive.
So how are companies to marry the extensive information requirements of traditional advertising, like television and print media, with emerging social media platforms used by billions? Take Twitter's 140-character limit, for example: Could a company compose even a single tweet that contained all the elements required by FDA? Should it even try?
At stake is nothing less than access to consumers in the new media environment, one in which those consumers are increasingly eschewing television and magazines for YouTube and Facebook.
But even as FDA has repeatedly confirmed that a full guidance document on social media-one required by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012-is on track for its anticipated July 2014 release date, FDA has been quietly working on another guidance document, one also focused on certain elements of social media.
New Social Media Guidance
Released on 13 January 2014, Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologicsis the agency's relatively concise attempt at describing how companies can submit their materials to FDA for review.
Those materials, FDA notes, include all modern "interactive promotional media," such as blogs, microblogs, social networking sites, online communities and live podcasts.
"Although some interactive promotional media are substantially similar in presentation and content to certain traditional promotional media, such as print media, FDA recognizes that in other cases they possess certain unique technological features and offer novel presentation and content features," the agency explains in the guidance.
At present, companies are supposed to submit advertising and promotional documents to FDA through Form FDA-2253 (human) or 2301 (veterinary) "at the time of initial dissemination," allowing FDA the opportunity to review materials more proactively instead of being forced to track them down themselves.
But as FDA concedes in the guidance, "at the time of initial dissemination" isn't always practical, especially when communications are being conducted in "real time," such as on Twitter. Should a company have to submit real-time reports for each tweet it sends out? And could FDA cope with the deluge of such information if industry was required to do so? While the guidance doesn't say so explicitly, regulators appear to have come to the conclusion that such an approach would be messy at best.
To cope, FDA said it "intends to exercise its enforcement discretion under certain circumstances due to the high volume of information that may be posted within short periods of time using interactive promotional media that allow for real-time communications."
If a firm complies with the approach recommended in the guidance, FDA said it will exercise its "enforcement discretion regarding the regulatory requirements for postmarketing submissions related to promotional labeling and advertising."
What to Report?
So what needs to be submitted, and when? The guidance explains both, noting that any materials posted to a social media site controlled either directly or indirectly ("under the control or influence of the firm") must submit materials to FDA's Office of Prescription Drug Promotion (OPDP), even if that influence is "limited in scope." FDA provided examples of influence being editorial control, preview or review privilege, or collaboration with the poster of the information.
However, if a company has given a company unrestricted grant money but otherwise contains no interest in posted materials, then those posted materials do not necessarily have to be submitted, FDA said.
The overriding point, according to FDA: "If a firm has any control of, or influence on, the third-party site, even if limited in scope, it is responsible for submission to FDA to meet the postmarketing submission requirements."
That control also extends to its employees when they are acting on behalf of the company, such as a company-directed tweet from an employee's private account. "For example, if an employee or agent of a firm, such as a medical science liaison or paid speaker (e.g., a key opinion leader) acting on the firm's behalf, comments on a third-party site about the firm's product, the firm is responsible for the content its employee or agent provides."
FDA said it recommended that firms "be transparent in disclosing its involvement on a site by clearly identifying the user-generated content (UGC) and communications of its employees or third parties acting on behalf of the firm."
When to Report?
The first half of the guidance deals with the "what," as in "what" needs to be submitted. The second half deals with the "when" and "how" of submission of promotional material to FDA.
For example, if a company is participating in active ("real-time") discussions on Twitter, it will need to submit information to FDA on a monthly basis, with a listing of all websites. What does not have to be submitted are screenshots of conversations. FDA said URLs to the firm's social media account would be sufficient so long as access to the sites remain unrestricted.
Sites controlled by third parties on behalf of the company will be subject to the same monthly reporting schedule, FDA wrote.
FDA will also need to be notified "on the first day the firm ceases to be active on a site," the guidance notes.
If a site is restricted, the firm should submit screenshots or other visual representations, also on a monthly basis. Formatting factors should also be taken into account when submitting communications to FDA, the guidance concludes.
Comments on the guidance are due in 90 days.
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics